ISPE – Turkey Affiliate

ISPE Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
15 June 2017

The fourth and final workshop of “Data Integrity Key for GMP Compliance” working group founded in 2016 within the ISPE Turkey Affiliate will be held on June 15, 2017 at Novartis Turkey Kurtköy Facilities, Istanbul.

After a short presentation on data integrity practices carried out within Novartis, the results from the Data Integrity Risk Inventory studies conducted via interworking groups in the past workshops and the entire path that the working group has taken for data integrity will be summarized in the workshop.

We look forward to your attendance.

PS: ISPE membership is a prerequisite for participation to the workshop.

Program (In Turkish)
Location (In Turkish)


CEO and President of ISPE John Bournas is on The Medicine Maker’s 2017 Power List

ISPE announced that CEO and President John Bournas was recognized as a top-10 Industry Influencer on The Medicine Maker’s 2017 Power List. The UK publication’s Power List celebrates 100 individuals “involved in bettering the pharma industry and bringing life-changing medicines to market” across four categories: Masters of the Bench, Industry Influencers, Business Captains, Champions of Change.

Bournas ranked seventh in the "Industry Influencers" segment. He was recognized for developing ISPE’s global initiatives and business operations, leading organizational efforts in solidifying working relationships with international regulators, and spearheading global initiatives such as the Drug Shortages Prevention Plan. Seven ISPE members were recognized on the 2017 Power List overall, including Andy Skibo, former ISPE Board Chair, and Jim Breen, ISPE Board Secretary.


Kadırga Vocational School Career Day
4 May 2017

On 4 May 2017, ISPE Turkey Affiliate contributed to the Career Day event of Kadırga Vocational School where the Pharmaceutical Manufacturing Technician Training Project is implemented.

Via the speeches and presentations of ISPE Turkey Affiliate’s Chair Fatma Taman, Cihan Sancaktaroğlu from BASF and Dündar Üngör from PharmaVision, the students were informed about career opportunities in the pharmaceutical and chemical industries in an interactive fashion.


"Supply Chain Traceability for Raw Materials" Workshop
24 April 2017

ISPE Turkey Affiliate's "Quality & Metrics" working group’s last workshop on "Supply Chain Traceability for Raw Materials" was held on 24 April 2017 at BASF Bostancı, Istanbul.

After the opening remarks of the leader of Quality&Metrics Working Group İlknur Gümüşeli Hırçın, BASF Information Systems and Supply Chain Management Manager Tolga Demirözü presented Traceability on Supply Chain Management topic with real-life examples.

In the second session of the workshop, Sezen Aksu Karataş, Bayer Turkey Supplier and Complaint Management Expert, and Bayer Turkey Supplier Management Expert and Chief Auditor Gökçe Yeter, discussed the issue of Supply Chain Traceability for APIs in detail.

We would like to thank BASF Turkey for hosting the workshop and wish to be together in the future workshops of our working group.


ISPE Turkey Student Chapter Career Day

ISPE Turkey Student Chapter’s Second Career Day was held at Istanbul University’s Cemil Birsel Conference Hall on 21 Nisan 2017.

Aligned with the theme of "Career in Pharmaceutical Sector", the organization was open to the participation of students from all pharmacy faculties, chemistry, chemical engineering and biology departments of universities in Turkey. ISPE Turkey Affiliate Office Manager contributed to the event with a presentation on Pharmaceutical Engineering and ISPE; then Derya Karayusufoğlu (Conval) and Çilem Diri (Bayer) who are members of ISPE’s Young Professionals Group founded in 2017 relayed information to students about membership and career benefits of being a member of ISPE Young Professionals Group when they will be graduated.

Congratulations to ISPE Turkey Student Chapter for the organization of the event that provided to students a perspective on career path through the presentations of many speakers who have expertise in various fields of the pharmaceutical industry; and thanks to all the speakers and students for their contributions.


ISPE Turkey Affiliate at Cleanroom 2017 Exhibition

The Cleanroom Technology, Maintenance and Equipment 2017 Exhibition which brought together the facility managers and cleanroom professionals who design and engineer extraordinary spaces for facilities was held on 20-22 April 2017 in ICEC – Lütfi Kırdar International Congress and Exhibition Center, Istanbul.

The exhibition provided a holistic approach with integrated “CBA High Technology Show” concept, Biotech Eurasia - Biotechnology and Life Sciences Exhibition and Expo Analytec - Analysis Technology and Laboratory Equipment Exhibition organised at the same time and at the same venue. On 21 April 2017, as part of the exhibition’s conference, Anel Group Mechanical Design Coordinator Nejat Babür shared information and his own experiences via the presentation titled “ISPE and Energy Efficient Cleanroom Design”.

In addition, information about the concept of pharmaceutical engineering and ISPE was shared at the ISPE Turkey Affiliate booth during the exhibition. As ISPE Turkey Affiliate, we would like to thank the visitors for their interest in our booth during the exhibition.


ISPE Turkey Affiliate
“From Cell to the Finished Product: A Holistic Look at Biotechnology”
14 April 2017

ISPE Turkey Affiliate’s 2017 Spring Seminar with the title of "From Cell to the Finished Product: A Holistic Look at Biotechnology" was held on 14 April 2017 at Barbaros Point Hotel – Istanbul with high participitation from pharmaceutical industry, academicians, suppliers and the Turkish Medicines and Medical Devices Agency (TMMDA).

The seminar, also attended by the Head of TMMDA Dr. Hakkı Gürsöz, was initiated with the opening remarks of ISPE Turkey Affiliate’s Chair Fatma Taman and later on, biopharmaceutical process development starting from the cell and biotechnological medium studies carried out in Turkey have been explained in detail by Dr. Aziz Çaylı, Chair of Florabio. Then, the production processes for biosimilar products and the comparability subject that is of utmost importance was addressed with a detailed presentation by Assoc. Prof. Devrim Demir Dora (Department of Pharmacology, Faculty of Medicine, Akdeniz University).

Matters on development and production of biosimilar monoclonal antibodies in our country were explained by Prof. Dr. Serdar Alpan, Turgut Pharmaceuticals Biotechnology Group Chair and experiences in the development and production processes of biosimilar products were shared by Dr. Ecz. İrem Yenice, Director of Biotechnology and R&D at Arven Pharmaceuticals, in connection with Novartis Turkey Country Director for Corporate Relations Selcen Erdem’s presentation on the contribution of high technological pharmaceutical products to the economic growth.

Technical issues with growing importance in the factory design for biotechnological products were included in the seminar in light of knowledge and experience of Anel Group Mechanical Design Coordinator Nejat Babür and criteria for selecting the right equipment in biotechnological productions were presented by Cem Erdem, Sartonet Biotechnology Project Manager. An interactive panel session was held to discuss the opinions and questions of the participants at the end of the seminar.

Following our seminar which achieved to provide a holistic view at biotechnological products and their specific production processes, we would like to thank all our speakers, our seminar sponsor BASF Turkey and all participants who showed great interest in our seminar; and wish to be together again in future activities and trainings on biotechnology subject.


Biotechnology Training for TMMDA

With ISPE Turkey Affiliate’s contributions, biotechnology training for Turkish Medicines and Medical Devices Agency (TMMDA) was held at Ankara on March 20, 2017 by Dr. Antonio Moreira from University of Maryland, Baltimore County (UMBC)-USA who is also a member of ISPE’s International Board of Directors.

The training that was conducted as live videoconference covered the topics of “Registration of Biological Products, Procedures for Biosimilar Registration with FDA and EMA, Biosimilar Product Development, Case Studies of FDA Approved Biosimilars” and it was very well received by the delegates of Turkish Medicines and Medical Devices Agency.


2017 ISPE Pharmaceutical Serialization Conference
8 – 9 May 2017, Sonesta Philadelphia - Rittenhouse Square, PA USA


The 2017 ISPE Pharmaceutical Serialization Conference will be held on 8-9 May 2017 in Philadelphia, USA. The unique conference features two keynote sessions, two industry panels, two featured workshops and eight more concurrent workshops focused on leveraging operations to maximize supply chain performance. General and concurrent session speakers include experts from the FDA, MHRA, the company presenters from the major pharmaceutical companies like Eli Lilly & Co, Johnson & Johnson Supply Chain, Pfizer, Sanofi Pasteur, Antares Vision, Sharp Packaging, Merck, Lachman Consultants and more.

Key issues addressed include:

  • Coordination with suppliers, CMOs, and other stakeholders
  • Data interconnectivity across the company and product life cycle for continuous improvement
  • Shop-floor tactics to prevent and address defects
  • Leveraging operations and investments to maximize supply chain performance
  • New frontiers for serialization - emerging science/technology issues
  • Case studies from around the world, including the hidden benefits and challenges of serialization

In the conference Timur Kabadayı, Managing Director from Conval Group Turkey, will share his knowledge and experience by the presentation titled as “Lessons Learned from Turkey’s Pharma Industry Experience with Serialization Launch and Implementation” while Arjun Guhathakurta, Life Science Director from Conval Group India will make a presentation titled as “Lessons Learned from Serialization Issues in India”.

Visit the conference website for detailed information and registration: http://ispe.org/2017-serialization-workshops


ISPE Turkey Affiliate at the 2nd Pharmaceuticals Ingredients, Raw Materials and Technologies Exhibition!


Pharmaist 2nd Pharmaceuticals Ingredients, Raw Materials and Technologies Exhibition will be held between 9-11 November 2017 at Istanbul Expo Center.

The exhibition which is concurrently planned with the 2nd Food and Nutritional Ingredients, Raw Materials and Technologies Exhibition, will comprise product groups like Turn-key Projects, Active Pharmaceutical Ingredients, Pharmaceutical Additives & Intermediates, Pharma Laboratory-Production and Test-Measurement Equipment, Pharmaceutical Packing and Packaging Technologies as well as Clean Room Technologies.

You are invited to visit ISPE Turkey Affiliate booth during the exhibition which aims to bring together the decision makers and executives from pharmaceuticals and food industries as well as managers of Purchasing, Quality Control, R&D, Marketing & Sales and Production Departments.

For detailed information and registration: http://www.pharmaist.net


ISPE Turkey Affiliate
"Supply Chain Traceability for Starting Materials" Workshop
24 April 2017

ISPE Turkey Affiliate's "Quality & Metrics" working group continues to its workshops with a new meeting on "Supply Chain Traceability for Starting Materials" on 24 April 2017 at BASF Bostancı, Istanbul.

We look forward to your attendance to this interactive workshop where several presentations on supply chain traceability will be performed, in addition to sectoral discussions on the subject matter.

PS: ISPE membership is a prerequisite for participation to the workshop.

Program (In Turkish)
Location (In Turkish)


ISPE and Pharmaceutical Manufacturing Technician Curriculum

The article of ISPE Turkey Affiliate’s Chair Fatma Taman about the “Pharmaceutical Manufacturing Technician” curriculum has been published on the January-February 2017 issue of Workshop Magazine. Fatma Taman highlighted the qualified personnel topic as one of the critical problems of the pharmaceutical industry in Turkey which strives to become the pharmaceutical production hub of its region. She expressed that some of the students who followed the Pharmaceutical Manufacturing Technician curriculum implemented for 8 years under the coordination of Kadırga Vocational High School and ISPE Turkey Affiliate, continue their training in vocational colleges, and some of them work at major companies in the pharmaceutical industry.


While pharmaceutical companies continue to support the curriculum by providing internship opportunities to the students, board members of ISPE Turkey Affiliate contribute with training programs on their subject matter expertise. Up to now in the 2016-2017 educational period, trainings were performed on topics such as pharmaceutical registration (Prof. Yıldız Özsoy Erginer - Istanbul University Faculty of Pharmacy), as well as GMP, Quality, Quality Assurance, Hygiene and Microbiology (Figen Ergin - BTS Bilişim).


ISPE Turkey Board Member Figen Ergin's seminar on
"Quality and Quality Assurance for Pharmaceuticals”
at Kadırga Vocational High School on 5 April 2017.


ISPE Turkey Affiliate
“From Cell to the Finished Product: A Holistic Look at Biotechnology”
14 April 2017

ISPE Turkey Affiliate’s 2017 Spring Seminar with the title of "From Cell to the Finished Product: A Holistic Look at Biotechnology" will be held on 14 April 2017 at Barbaros Point Hotel – Istanbul.

We look forward to your participation to this important seminar focused on biotechnological products and their specific manufacturing attributes.


Seminar Program (In Turkish) | Resumes (In Turkish) | Location (In Turkish)




ISPE Turkey Affiliate
"QbD & PAT" Workshop
13 March 2017


QbD* & PAT** Workshop of ISPE Turkey Affiliate was held on 13th of March, 2017 at Santa Farma Pharmaceuticals.

Quality by Design and PAT applications were discussed throughout the presentations of Qbd & PAT Working Group Leader Assoc. Prof. Buket Aksu and Bayer Turkey Quality Project Manager Mehmet Çalıkoğlu.

We would like to thank Santa Farma Pharmaceuticals for their hospitality and all the attendees for their contributions. We wish to be together at future workshops and seminars.

*QbD: Quality by Design
**PAT: Process Analytical Technology


ISPE Turkey Affiliate at CPhI Istanbul Exhibition!


CPhI Istanbul which gathered again regional drug manufacturers, suppliers, solution and technology providers was held on 8-10 March 2017 at Istanbul Expo Center (IFM), Istanbul - Turkey. Following the record number of participants and visitors in 2016, CPhI Istanbul 2017 continued to serve as a unique forum for domestic and foreign pharmaceutical industry representatives and ISPE Turkey Affiliate contributed to the exhibition with sessions and a booth.

Our Chair Fatma Taman and Board member Figen Ergin contributed as speakers to the Fortune Turkey Women's Networking Meet-Up. ISPE workshop on “Importance of API for Registration and Regulatory Requirements for API Variations” was leaded by Nezihe İçduygu and ISPE Turkey Affiliate booth was visited by many visitors during the exhibition.


ISPE Turkey Affiliate
"QbD & PAT" Workshop
13 March 2017

ISPE Turkey Affiliate's QbD* & PAT** Workshop will be held on 13th of March, 2017 at Santa Farma Pharmaceuticals.

We wish to be together at the workshop where QbD and PAT concepts and applications will be discussed throughout the presentations of Our Vice-Chair and QbD & PAT Working Group Leader Assoc. Prof. Buket Aksu and Bayer Turkey Quality Project Manager Mehmet Çalıkoğlu.

*QbD: Quality by Design
**PAT: Process Analytical Technologies

PS: ISPE membership is a prerequisite for participation to the workshop.

Program (In Turkish)
Location (In Turkish)


ISPE Turkey Affiliate met with the students of Kadırga Vocational School!


The first of the seminars for 2017 in the scope of ISPE Turkey Affiliate’s cooperation with Kadırga Vocational School was conducted by Our Board Member Figen Ergin on 1st of March 2017.

Within the scope of the seminar, GMP concepts were introduced and discussions were made around the questions of “What is GMP? Why is GMP important in drug manufacturing?" with the students.


ISPE Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
23 February 2017


The third workshop of “Data Integrity Key for GMP Compliance” working group founded in 2016 within the ISPE Turkey Affiliate was held with the sponsporship of BTS and Conval Group on February 23, 2017 at Hilton Kozyatağı, Istanbul with broad participation from the pharmaceutical industry.

The workshop started with opening remarks of Fatma Taman (ISPE), Nadi Tanca (BTS) and Timur Kabadayı (Conval Group); then continued with our working group leader Figen Ergin’s presentation on data integrity guidelines and previous studies. Data Integrity Risk Inventory preparation studies were performed in an interactive group study fashion during the afternoon session of the workshop.

We would like to thank BTS and Conval Group for their sponsorships as well as all our attendees for their contributions. We look forward to working together in future workshops and seminars on this topic.


ISPE Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
23 February 2017

The third workshop of ISPE Turkey Affiliate “Data Integrity Key for GMP Compliance” working group will be held on February 23, 2017 at Hilton Kozyatağı, Istanbul.

Following information exchange on data integrity guides and previous studies, the workshop will continue with studies for Data Integrity Risk Inventory. We look forward to your attendance.

PS: ISPE membership is a prerequisite for participation to the workshop.

Program (In Turkish)
Location (In Turkish)


ISPE Turkey Affiliate at CPhI Istanbul Exhibition!


CPhI Istanbul which will gather again regional drug manufacturers, suppliers, solution and technology providers will be held on 8-10 March 2017 at Istanbul Expo Center (IFM), Istanbul - Turkey.

Following the record number of participants and visitors in 2016, CPhI Istanbul 2017 continues to serve as a unique forum for domestic and foreign pharmaceutical industry representatives and ISPE Turkey Affiliate will contribute to the exhibition with a booth and two workshop sessions.

The workshop on “Importance of API for Registration and Regulatory Requirements for API Variations” leaded by Nezihe İçduygu will take place at the Seminar Area on 9 March, 2017 Thursday (15:00-17:00) and the workshop about “What is Quality by Design (QbD)? Associated Regulations and Its Importance for APIs” organised by Assoc. Prof. Buket Aksu will be held on 10 March, 2017 Friday (14:00-16:00).

You are also invited to ISPE Turkey Affiliate booth during the exhibition (Booth number: 10G11).

For more information about the exhibition and conference: http://www.cphi.com/istanbul/
For registration: https://registration.n200.com/survey/3h182g05p4k1y


ISPE Turkey Affiliate at Cleanroom 2017 Exhibition


The Cleanroom Technology, Maintenance and Equipment 2017 Exhibition which will bring together the Facility managers and Cleanroom professionals who design and engineer extraordinary spaces for facilities will be held on 20-22 April 2017 in ICEC – Lütfi Kırdar International Congress and Exhibition Center, Istanbul.

Cleanroom Exhibition is going to be much more fruitful since the exhibition will be organised at the same time, at the same venue with Biotech Eurasia - Biotechnology and Life Sciences Exhibition and Expo Analytec - Analysis Technology and Laboratory Equipment Exhibition.

Within the exhibition that will provide a holistic approach with integrated “CBA High Technology Show” concept, you are invited to Anel Group Mechanical Design Coordinator Nejat Babür’s presentation on “ISPE and Energy Efficient Cleanroom Design” on 21 April 2017 Friday at Aspendos Hall (13:00 – 13:40) as well as ISPE Turkey Affiliate booth (Booth no: 510) during the entire exhibition.

For more information about the exhibition: http://www.expocleanroom.com/index.php?language_code=en


ISPE 2017 Europe Annual Conference
“Lead and Manage Future Operations”
3-5 April 2017, Barcelona


ISPE 2017 Europe Annual Conference with the theme of “Lead and Manage Future Operations” will be held on 3-5 April 2017 in Barcelona, Spain.

This year the conference will focus on “Pharma Manufacturing 2025” and the way to achieve a modern, agile and flexible production landscape with the topics like Continuous Manufacturing, Sterile and Aseptic Manufacturing, Active Pharmaceutical Ingredients, Regulatory Updates for the Commercial and Clinical Supply Chain, Mass Serialisation and Investigational Products.

Prominent questions like “What will the main regulatory trends be by 2025?, How will the current technology platforms evolve?, What will the required skillsets and capabilities of the future workforce be?, What does the facility of the future look like and how will operations be managed?, How can we guarantee safe supply: no counterfeits, no drug shortages?” will be explored and discussed during the conference.

Please visit the conference website for detailed information and registration: http://www.ispe.org/2017-europe-annual-conference


ISPE Turkey Affiliate Industry Gathering
“Engineering Approach at the Facilities of the Future”
26 January 2017


The third of “Industry Gatherings” that ISPE Turkey Affiliate organizes as afternoon meetings based on current issues was held on 26 January 2017 at The Grand Tarabya, Istanbul and covered the topic of “Engineering Approach at the Facilities of the Future”.

Following the presentation about “Engineering Approach at the Facilities of the Future” given by Anel Group Mechanical Design Coordinator Nejat Babür, Manufacturing Site Leader of Pfizer Turkey Devrim Çavuşoğlu gave information about the "Excellence in Pharma Engineering" Working Group established within ISPE Turkey Affiliate and working group’s road map for 2017 was created with the contributions of participants.

We hope to be together at the further organizations of our working group.


Pharmaceutical Engineering Conference, Amman – Jordan


Chair of ISPE Turkey Affiliate Fatma Taman, contributed to the Pharmaceutical Engineering Conference, organised by Agon Academy on 7-8 January 2017 in Amman – Jordan, with presentations on “Introduction to Pharmaceutical Project Management” and “Successful Purchasing/Procurement Approaches for Pharmaceutical Projects”.


ISPE Turkey Affiliate Industry Gathering
“Engineering Approach at the Facilities of the Future”
26 January 2017

The third of “Industry Gatherings” that ISPE Turkey Affiliate organizes as afternoon meetings based on current issues, will be held on 26 January 2017 at The Grand Tarabya, İstanbul and will cover the topic of “Engineering Approach at the Facilities of the Future”.

We hope to be together at our Industry Gathering where in addition to presentation on “Engineering Approach at the Facilities of the Future”, information will be provided about the "Excellence in Pharma Engineering" Working Group to be established within ISPE Turkey Affiliate in 2017.

Date: January 26, 2017 – Thursday
Time: 17:00-19:00
Location: The Grand Tarabya

Program (In Turkish)
ISPE Turkey Affiliate Young Professionals Group


ISPE Turkey Affiliate Young Professionals Group will be established in 2017 with the participation of individuals just starting in the pharmaceutical industry, one to four years after university graduation.

To access resources designed for Young Professionals and to develop business network, you can become a member of ISPE Young Professionals Group with a fee of 99 Euro instead of 149 Euro by taking advantage of discounted membership benefits.

 

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Affiliate of the Year Award

10 years